{"id":3637701,"url":"https://alion.io/job/integer-regulatory-affairs-specialist","title":"Regulatory Affairs Specialist","company":{"id":6616,"name":"Integer","domain":"integer.net","url":"https://alion.io/company/integer","size_band":"1001-5000","is_staffing_agency":false,"employer_type":"direct","is_intermediary":false,"listed_via":null,"ats_vendor":"Workday","truth_index":{"grade":"B","score":81,"open_postings":32,"ghost_share":0,"stale_share":0.969,"repost_share":0,"time_to_fill_p50_days":21,"computed_at":"2026-11-04T06:34:25Z"}},"role":"Biotech","role_family":"Biotech","seniority":"junior","employment_type":"full_time","work_mode":"on_site","remote_scope":null,"remote_scope_basis":null,"remote_working_hours":null,"hiring_geo_confidence":"structured","locations":["Plymouth, United States"],"countries":["US"],"hiring_countries":[],"hiring_countries_total":0,"salary":{"min":73425,"max":107690,"currency":"USD","period":"year","gross":null,"usd_annual":107690},"salary_estimate":null,"experience_years_min":1,"visa_sponsorship":false,"relocation_package":false,"has_equity":false,"technologies":[{"name":"CAPA","optional":false},{"name":"EU MDR","optional":false},{"name":"Microsoft Office","optional":false}],"status":"live","first_seen_at":"2026-11-02T21:10:53Z","employer_posted_date":"2026-11-02","last_verified_at":"2026-11-04T00:37:49Z","board_verified":true,"closed_at":null,"days_open":1,"trust":{"level":"ok","repost_count":null,"flags":[],"days_open":1},"description":"By living according to a common set of values, we create a culture that unifies, embraces the uniqueness we all bring to the company, and positions Integer for long-term success.\nAt Integer, our values are embedded in everything we do.\nCustomer \nWe focus on our customers’ success\nInnovation \nWe create better solutions\nCollaboration \nWe create success together\nInclusion \nWe always interact with others respectfully\nCandor \nWe are open and honest with one another\nIntegrity \nWe do the right things and do things right\n\nWho are we?\nInteger is a global organization providing innovative, high-quality technologies and manufacturing to Medical Device OEM’s (original equipment manufacturers) to enhance the lives of patients worldwide and a provider of high-end niche batteries for specialized applications in the energy, military, and environmental markets. We are guided by our six Values, including focus on Customers, Innovation, Collaboration, Inclusion, Candor, and Integrity. Working at Integer means you are part of a team passionately pursuing excellence in all that we do and always reaching for the next great achievement.\nWhat you’ll do in this role:\nThe primary purpose of this job is to provide team support to Regulatory Affairs managers and department management in being responsible for capturing, archiving, and publishing of regulatory documents. Develop strategies and prepare submissions for national and international product registrations. Prepares and maintains regulatory files, regulatory reports, and databases.\nYou adhere to Integer’s Values and all safety, environmental, security and quality requirements including, but not limited to: Quality Management Systems (QMS), Safety, Environmental and Security Management Systems, U.S. Food and Drug Administration (FDA) regulations, company policies and operating procedures, and other regulatory requirements. \nRegulatory Submissions/Approvals\nYou will be responsible to prepare national and international regulatory submissions for Integer owned devices. You will provide team support for product submissions and consult with multiple sources for information to prepare submissions. \nYou will review Change Requests that require regulatory review and approval to ensure compliance with national and international government regulations. \nYou will prepare and maintain no-file decisions, external regulatory databases (ex. FDA FURLS, GUDID, EUDAMED, etc.), and product files consistent with Integer quality system requirements and department procedures.\nCustomer Support\nYou will coordinate the review of and responses to customer requests/queries for information related to process and products and maintain respective tracking logs.\nYou will participate in customer notification of changes and assist in maintaining respective tracking log.\nYou will obtain external regulatory documents in support of customer requests (ex. CFG’s, CFS’s) and facilitate the legalization/authentication/apostilling of such documents, as required.\nExternal and Internal Audits\nYou may perform and support internal quality system audits in accordance with Integer quality management system procedures and according to the external requirements as indicated in the Integer Quality Manual.\nYou will participate in regulatory and Notified Body audits as a regulatory team member in either back room or front room activities and may compile, organize and track responses to findings.\nQuality System Responsibilities\nYou will perform work on projects where you will follow Integer’s standard quality management system methodologies to investigate opportunities for process improvements.\nYou are expected to collaborate with others in the exchange of information, ask questions and regularly check for understanding in support of your development as a regulatory professional.\nYou embed Quality within the Regulatory discipline - “I own Quality.” You are a standard bearer for Quality in everything we do at Integer, by assuring adherence to our Quality Management System (QMS), facilitating and/or contributing to corrective and preventive actions, and contributing to the successful attainment of our quality KPI’s and journey to differentiated quality.\nYou may perform other duties as needed and as directed by your line of supervision.\nManufacturing Excellence Imperatives\nProvide support of Integer’s Manufacturing Excellence and Market Focused Innovation Strategies \nParticipation or Leadership in Site Hoshin Planning, Quality Planning, Validation master plans and associated quality improvement imperatives\nProvide data as required for QA RA weekly and monthly metrics, supporting the walk to differentiated quality. \nSupport Leadership of Sustained Change ensuring customer change notifications are initiated and completed, as necessary, and supporting continuous improvement activities as required.\nSupport the standardisation of workplace organization & visual controls (5S), Manufacturing Standard Work, and robust training & certification programs where applicable. \nAssociate Engagement promoted through the adoption of standardized problem solving. methodologies, behaviour-based safety programs, and improvement idea and suggestion systems.\nSystems & Process Optimization through adoption of principles of built in quality. \nHow you will be measured:\nThe specific measures listed below may be subject to change and are not intended to be an all-inclusive list.\nSafety is our highest priority; you will be an active supporter of the Integer Environmental, Health & Safety programs. \nYou will have defined Goals and Objectives specifying key projects and expected milestones to achieve. \nAchievement of site quality KPI’s\nInnovation and ideation are critical aspects of your role, and you will be expected to generate continuous improvement suggestions and support the implementation of them.\nWhat sets you apart:\nPreferably, you have earned, as a minimum, a bachelor’s degree and have at least 1 year of relevant experience. Candidates who do not meet the education requirement may be considered if they have a minimum of 3 years’ relevant medical device or other regulated industry experience. \nWhile you will have occasional support and guidance from more experienced regulatory professionals, supervisors or managers, you will demonstrate the ability to work independently as well as collaboratively with other associates and cross functional teams.\nYou demonstrate an understanding of the European Medical Device Regulation, US FDA regulations and other applicable regulations as identified in the Quality Manual.\nYou demonstrate a solid technical aptitude with the ability to be an effective contributor to a team or produce results of a technical nature as an individual.\nYou demonstrate competencies in both written and oral communications.\nYou are highly organized and able to work and track multiple projects simultaneously.\nYou possess intermediate to advanced skills using Microsoft Office (PowerPoint, Visio, Project, etc.)\nYou possess a positive, can-do attitude with an underlying belief that failure is not an option.\nSalary Range $73,425 - $107,690\n\nOur total rewards program is designed to attract, retain, and motivate associates to contribute to Integer’s success. Our compensation program includes base salary and a cash-based incentive program supporting our pay-for-performance philosophy. We provide a comprehensive benefits package with immediate eligibility including medical, dental, vision, disability, life insurance, and adoption benefits. Parental leave is available after one year. Optional employee-paid programs include supplemental life insurance, critical illness, hospital indemnity and accident insurance. Employees are immediately eligible to participate in the 401(k) plan with company matching contributions. We provide 80 hours (10 days) of company designated holidays per year plus an annual allotment of paid time off.\n\nU.S. Applicants: Equal Opportunity Employer. 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